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Autoinjector, Pre-filled syringe · 1 trial · 1 indication
The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a "Yes" or "No" response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Peginterferon via auto-injector device. All participants will receive Peginterferon in a cross-over design. |
| 2 | ACTIVE_COMPARATOR | Peginterferon via pre-filled syringe. All participants will receive Peginterferon in a cross-over design. |
| Name | Type | Description |
|---|---|---|
| Autoinjector | DEVICE | Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks. |
| Pre-filled syringe | DEVICE | Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks. |
Inclusion Criteria: * adult patients, \>/=18 years of age * chronic hepatitis C * on treatment with peginterferon alfa-2a for \>/= 12 weeks at baseline, or treatment-naïve for peginterferon alfa-2a Exclusion Criteria: * history or evidence of decompensated liver disease * autoimmune hepatitis * h...
The Autoinjector, Pre-filled syringe is used for the administration of peginterferon alfa-2a (Pegasys) in patients with chronic Hepatitis C. It is an investigational delivery system being studied in a Phase 1 clinical trial to compare administration by autoinjector versus pre-filled syringe.
Roche Holding AG (ticker: RHHBY) is developing the Autoinjector, Pre-filled syringe. The company is conducting a clinical trial to evaluate this delivery method for peginterferon alfa-2a in patients with chronic Hepatitis C.
The Autoinjector, Pre-filled syringe is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with results not yet reported.
The Autoinjector, Pre-filled syringe is associated with one completed clinical trial, NCT01087944, titled 'A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C.' This Phase 1 trial enrolled 60 participants in the United States.
The Autoinjector, Pre-filled syringe is a delivery device for peginterferon alfa-2a, which is marketed as Pegasys. The trial compares administration of Pegasys via autoinjector versus pre-filled syringe, but the device itself is not the drug.